The present invention relates to a method of assisting a user in a medical self treatment, said self treatment comprising a plurality of actions.
The present invention also relates to a system/an apparatus for assisting a user in a medical self treatment, said self treatment comprising a plurality of actions.
In the following a user/patient will be a patient having diabetes.
For a number of years it has been possible to purchase various devices for the treatment of diabetes, e.g. for injecting insulin, for measuring blood sugar (such a device is referred to as BGM in the following), for withdrawing blood samples, and other accessories, the purpose of which is to enable the patient to nurse his disease discretely and with a high standard of safety.
Many diabetic patients are elderly people who can easily get insecure with respect to the medical equipment. It is very reassuring and therefore also very important that the user can have feedback from the system which confirms to the user that everything is OK right from the technical function of the system to the patient""s physiological condition. This stretches out a psychological safety net under the patient, which contributes to improving the quality of life of patients having a disease such as diabetes.
Traditionally, diabetic people live under strict rules of xe2x80x9cdo""s and don""tsxe2x80x9d. There is a historical need in order to comply with a therapeutic regimen. The purpose of this being a well controlled blood glucose level (BGL) and thereby a much lesser risk of later complications. This is a highly undesirably situation from a xe2x80x98quality-of-lifexe2x80x99 point of view. It often results in bad moodxe2x80x94which is known to lead to a poor BGL regulation. Thus an evil circle is created which is hard for the diabetic to break.
Additionally, in certain cultures/societies there is a reluctance against using syringes/needles to administer medication and people therefore choose alternative ways to try to comply with a regimen. However, this often has the unfortunate result that people choose alternatives that do not fully or at all correspond to the optimal regimen and thereby choose wrong alternatives with adverse effects.
Further, the metabolism is a very complex and dynamic system. It is very hard to get and maintain an overview for the diabetic as many factors play a role. It is very likely that the diabetic looses an overview or relies on too simple rules of operation or eventually neglect the illness.
Various systems trying to ease the hazels of diabetes have been proposed over time. These systems have basically an accounting role and simply keep track of whatever input the user specifies. In these systems input of food and exercise are usually a task that the user needs to initiate. Systems that rely on the user to take action can be hard to make function well due to the user""s reluctance to deal with it.
Patent specification WO 95/32480 discloses a medical information reporting system which has a patient sensor device controlled via a patient operated interface device by a micro-controller which writes data to a memory and a report writer. The specification further discloses a warning algorithm with zone boundary values which is specified by the user and consent to by a physician. This system simply keep track of whatever input the user specifies.
Patent specification WO 94/24929 discloses a patient support and monitoring system, which has a database located at a remote location for collection of information in a remote database from sensors and a medicine administration system. This system also keep track of whatever input the user specifies and may initiate a medical reaction on the basis of received parameters.
The object of the invention is to provide a method which provides a user with a freedom of operation with respect to a self-treatment.
This is achieved by guiding the user with respect to a self treatment by presenting options/possibilities in such a way that compliance to a regimen may be obtained in numerous ways.
More particularly, the invention relates to a method of assisting a user in a medical self treatment, said self treatment comprising a plurality of actions, said method comprising the steps of
collecting in a one or more databases data representing values of parameters relevant for said self treatment, where said method further comprises the step of
processing said one or more databases to provide the patient with the alternate choices between tow or more actions and a corresponding dose for each two or more actions.
Hereby, the user""s self-treatments change from restrictions to possibilities thereby enhancing the overall xe2x80x98quality-of-lifexe2x80x99 for the user and better ensuring that the user""s self-treatment complies better or fully with a specified regimen by choosing proposed choices which complies with the regimen. This avoids that the user chooses actions and alternatives which do not fully or at all correspond to the optimal regimen due to a lack of a clear overview of the complex factors involved in the self-treatment.
By providing the user with a number of options he maychoose the one(s) he likes best and still obtain the right and full treatment instead of choosing the easiest and most appealing course of action on his own, which may be wrong or insufficient and result in adverse effects.
Additionally, the possibility of choices fulfilling a prescribed regimen makes the patient feel more in control of the treatment and enhances the therapeutic value of the treatment and improves the patient""s ability to adapt his treatment to his daily life.
Additionally, the user""s feeling of being ill is reduced, since the user has options of choices instead of a dictation of actions.
An additional object of the invention is to estimate one or more future values for one of said parameters, in order to obtain information of the user""s condition in the near future, hereby enhancing the possibilities of presenting better/more relevant choices.
One way of estimating one or more future values may be done on the basis on a dynamic model representing the human metabolism.
An additional object of the invention is to provide effective monitoring of electronic data/information which are used by a patient for self-treatment of a disease, so that a greater level of safety, both functionally and emotionally, and an effective feedback to the patient are obtained.
The invention also relates to computer system having means for executing a program, where the program when executed is to make the computer execute the method according to claims 1-19.
By computer system is meant a system comprising processing means and being programmable at one time or another in order to execute a set of instructions/commands like a system for the self-treatment of a patient e.g. comprising one or more of sensor, medication administering device, data collection, and displaying means or a general computer system as a PC, laptop, palmtop, or a system having at least one device comprising a micro controller adapted to execute a program (either in hard- and/or software), and so on.
The invention further relates to a computer readable medium having a program recorded thereon, where the program when executed is to make the computer execute the method according to claims 1-19.
The computer readable medium may e.g. be a CD-ROM, magnetic disk, ROM circuit, a network connection or generally any medium that may provide a computer system with information of how to execute instructions/commands.
The above mentioned system and method need as good as possible data collection in order to present relevant and useful choices/proposals to the user. In a preferred embodiment a system/method relating to individual apparatuses, which are provided with electronic communications equipment so that the apparatusesxe2x80x94when in a state of mutual communicationxe2x80x94frequently exchange information between them, are provided. Hereby a greater functional safety can be achieved and the total data capacity of the system can be increased, so that the feedback possibilities, e.g. of the system checking that every apparatus is OK and set up properly and of the patient be given a number of possible and up to date choices to choose from in a given situation, are increased.
The individual devices may be arranged for various respective functions relevant to the treatment of e.g. diabetes, such as: a lancet device, a body fluid analyser, one or more drug administration apparatuses for administering a predetermined dose of medication to the patient. Further, there may be a number of other aids which the diabetic patient uses, e.g. test strips for the blood analyser, needles, napkins for wiping off blood, extra insulin cartridge, glucose tablets, waste containers, etc.
The apparatuses according to the example may communicate information such as: amount of medication, type of medication, the concentration of relevant substances in the body e.g. body fluid level/concentration, time stamp, amount of food (e.g. amount or units of carbohydrate), measurement of physical activity, notification (e.g. alert and warning) to the patient, body characteristics (e.g. weight, blood pressure etc.) and inventory logistics. This ensures that relevant information, for e.g. a drug administration system like a doser, i.e. number of units of insulin, insulin type and time and date for administering, can automatically be stored, displayed, received and transmitted to and from all the relevant apparatuses and more particularly in one or more database accessible by a system/method for processing in order to obtain the results described above and later. The doser could also receive information regarding a predetermined number of units of insulin to be administered and automatically set the amount of medication to be administered by electromechanical means. In this way elderly and handicapped people do not have to set the relevant amount of medication themselves but just activate the doser and a confirmation of the actual administered dose may be used as input.
Other types of drug administration systems like an inhaler adapted to administer a dose of medication in an air stream or a tablet dispenser may be included instead or in combination with the doser. The inhaler and/or tablet dispenser may also communicate with the other units for relevant information like the doser according to the invention.
It is especially useful to transmit the data from all apparatuses to the functional master module/apparatus containing the highest priority program for safe keeping, calibration and updating of data and possible transmission to e.g. an external unit like a PC or database for further data acquisition, storage and processing. In this way the patient, a physician or an expert care-team can obtain the behavior over time of the patient, and a check for compliance to a diet or treatment given to the patient by a physician or an expert care-team can be made. This enhances the possibility of choices according to the invention.
Additionally, it is also possible for the patient to manually input information about the treatment. This information may be historic information as well as information about a future scheme (behavioral pattern) e.g. planned physical exercise, administering of insulin, intake of food and other medications. This information may be collected and thus serve as an electronic diabetes diary or may be used to notify the patient through the receiving means as to whether the planned actions are dangerous or not. The patient can further receive recommended amounts of medication, exercise, food, etc. from a physician, from an expert-team or automatically. All this information may be used to estimate one or more future parameter values, e.g. BGL.
It is evident that since the apparatuses are to be carried by the patient, there is a potential lack of space for an advanced input device e.g. a keyboard. Therefore, information which cannot be input on a standardized form e.g. personal comments on the treatment may be typed into the apparatus by the patient using a simple input device once and can subsequently be chosen from a list, if needed again.
Preferably, all the apparatuses of the system exchange information so that every apparatus (or at least every apparatus within range) is updated with the combined information, but still one particular apparatus is the link to any outside systems, so that every bit of information is mirrored for better safety and backup. This demands a greater amount of total memory capacity for the system.
For a BGM according to an embodiment of the invention the relevant information could be the time and date for measurement, measured level/concentration of blood glucose which could be stored or transmitted to another apparatus.
For a doser according to an embodiment of the invention the relevant information could be the type of medication (e.g. long acting or short acting insulin), number of units of insulin to be administered and the time and date of the administering. This information could both be set manually by the patient or remotely by a physician, an expert care-team or automatically.
For an inhaler according to an embodiment of the invention the relevant information could be the type of medication, the number of units of medication to be administered and the time and date of the administering. This information could both be set manually by the patient or remotely by a physician, an expert care-team or automatically.
For a storage container according to an embodiment of the invention the relevant information could be used to keep track of the contents of the container so that every time an object (e.g. cartridge, needle, etc.) is used, the storage container will update the inventory list. This list could be transferred to a unit of highest priority immediately or later, which could in turn update the patient""s total holdings of objects, so that the system could notify the patient when he should order a new stock of objects in order to keep all the different proposed actions available. The ordering could also be done automatically by the system if the inventory list is transferred to an external unit, which greatly improves the confidence, comfort and safety of the patient.
For a tablet dispenser according to an embodiment of the invention the relevant information could be the number of dispensed tablets, the number of remaining tablets, the time of dispension and the type of dispensed tablets. The dispenser could store and/or communicate this information to an available unit of highest priority or other units within communication range.
In the following a preferred embodiment according to the invention is described in detail. This particular embodiment is meant as one example only of the invention and should not as such limit the scope of protection as claimed in the appended claims.
The term xe2x80x9cMargin Makerxe2x80x9d is used in the following for a method/system according to the invention.
The invention will now be explained in detail with reference to the FIGS. 1-8, in which